Needleless connector with support member

ABSTRACT

Needleless connectors are described herein. A needleless connector includes a body, a valve element at least partially disposed within the body, and a base. The valve element includes a cylindrical portion having an outwardly extending flange at a distal end. The flange has a bottom surface with an outer area and an inner area. The base includes a rim having a top surface that is in contact with an outer area of the flange of the valve element, the rim defining a recess with a bottom surface separated from the top surface of the rim, and at least one support member having a top surface spaced apart from the top surface of the rim and configured to resist deformation of the flange toward the recess.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.14/745,199, filed Jun. 19, 2015, entitled, “NEEDLELESS CONNECTOR WITHSUPPORT MEMBER,” which is a continuation of U.S. application Ser. No.13/829,187, filed Mar. 14, 2013, now U.S. Pat. No. 9,089,682, entitled,“NEEDLELESS CONNECTOR WITH SUPPORT MEMBER,” the disclosure of each ofwhich is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present disclosure generally relates to connectors, and, inparticular, to needleless connectors.

BACKGROUND

Medical treatments often include the infusion of a medical fluid (e.g.,a saline solution or a liquid medication) to patients using anintravenous (IV) catheter that is connected though an arrangement offlexible tubing and fittings, commonly referred to as an “IV set,” to asource of fluid, for example, an IV bag. Certain needleless connectorsmay be used in an IV set and may have a self-sealing port to preventleakage of fluid when a mating medical implement is decoupled from sucha needleless connector. Additionally, a needleless connector may includea mechanical valve, for example, a collapsible valve comprising aflexible material for providing the self-sealing port and controllingthe flow of fluid within the IV set.

When a needleless connector is used in an IV set but not being accessed(i.e., a mating medical implement is not coupled to the self-sealingport), the needleless connector may be subjected to back pressure fromthe flow of fluid within the IV set. For example, back pressure can becaused by a patient's blood pressure, by an injection made at adifferent connector in the IV set, or by a pump utilized in the IV set.Back pressure applied to some needleless connectors may cause the sealof the self-sealing port to be breached. If the seal of a non-accessedneedleless connector becomes breached due to back pressure, then somemedical fluid from the IV set may undesirably accumulate in the neckarea of the self-sealing port or be expelled from the system.

SUMMARY

The disclosed subject matter relates to connectors having supportmembers for collapsible valves. In certain embodiments, a needlelessconnector is disclosed that comprises a body; a valve element at leastpartially disposed within the body, the valve element comprising acylindrical portion having an outwardly extending flange at a distalend, the flange having a bottom surface with an outer area and an innerarea; and a base comprising a rim having a top surface that is incontact with at least a portion of the outer area of the flange of thevalve element, the rim defining a recess with a bottom surface distallyseparated from the top surface of the rim, and at least one supportmember extending from the rim into the recess so as to contact the innerportion of the bottom surface of the flange.

In certain embodiments, a needleless connector is disclosed thatcomprises a housing comprising proximal and distal ends, a body having afemale fitting with a port at the proximal end, a base having a malefitting at the distal end, and an internal cavity; a valve elementdisposed within the internal cavity and comprising a proximal portionhaving a smiley cut, a cylindrical portion coupled to a distal end ofthe proximal portion, and an outwardly extending flange coupled to thedistal end of the cylindrical portion, the flange having a bottomsurface with an outer area and an inner area; and a base comprising arim having a top surface that is in contact with at least a portion ofthe outer area of the bottom surface of the flange of the valve element,the rim defining a recess in the base, the recess having a bottomsurface distally separated from the top surface of the rim, and aplurality of protrusions each extending from the rim into the recess soas to contact the inner portion of the bottom surface of the flange,wherein the proximal portion of the valve element blocks the port whenthe female fitting of the needleless connector is not mated with acompatible male connector.

It is understood that various configurations of the subject technologywill become readily apparent to those skilled in the art from thedisclosure, wherein various configurations of the subject technology areshown and described by way of illustration. As will be realized, thesubject technology is capable of other and different configurations andits several details are capable of modification in various otherrespects, all without departing from the scope of the subjecttechnology. Accordingly, the summary, drawings and detailed descriptionare to be regarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding and are incorporated in and constitute a part of thisspecification, illustrate disclosed embodiments and together with thedescription serve to explain the principles of the disclosedembodiments. In the drawings:

FIG. 1A-1B are cross-sections of a conventional needleless connector.

FIG. 1C is a perspective view of the base of the conventional connectorof FIG. 1A.

FIG. 1D is a cross-section of the conventional connector of FIG. 1A whenmated with compatible male connector.

FIG. 1E is an enlarged view of a portion of FIG. 1D.

FIG. 1F is a cross-section of the conventional connector of FIG. 1A whenthe conventional connector is in a fluidly connected, but non-accessedstate.

FIG. 2 is an exploded view of an exemplary needleless connector, inaccordance with various aspects of the present disclosure.

FIG. 3 is a top view of the base of FIG. 2 , in accordance with variousaspects of the present disclosure.

FIGS. 4-5 are top views of other embodiments of the base, in accordancewith various aspects of the present disclosure.

FIG. 6A is a cut-away perspective view of the assembled needlelessconnector of FIG. 2 , in accordance with various aspects of the presentdisclosure.

FIGS. 6B-6D are cut-away perspective views of the complete connector atlocations shown in FIG. 6A, in accordance with various aspects of thepresent disclosure.

FIG. 7 is a cross-section of an exemplary needleless connector of FIG. 2when the exemplary needleless connector is in a fluidly connected, butnon-accessed state, in accordance with various aspects of the presentdisclosure.

DETAILED DESCRIPTION

The disclosed self-sealing, needleless connector incorporates aflexible, collapsible valve disposed within a body of the connector. Abottom surface of the collapsible valve is in contact with supportmembers of a base that support the collapsible valve when back pressureis applied to the needleless connector in order to prevent deformationof the collapsible valve toward the base. By preventing deformation ofthe collapsible valve toward the base, the back pressure deforms thecollapsible valve in a manner that further improves the seal of theneedleless connector when in a non-accessed state.

The detailed description set forth below is intended as a description ofvarious configurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The detailed description includes specific details for thepurpose of providing a thorough understanding of the subject technology.However, it will be apparent to those skilled in the art that thesubject technology may be practiced without these specific details. Insome instances, well-known structures and components are shown in blockdiagram form in order to avoid obscuring the concepts of the subjecttechnology. Like components are labeled with identical element numbersfor ease of understanding. Reference numbers may have letter suffixesappended to indicate separate instances of a common element while beingreferred to generically by the same number without a suffix letter.

While the following description is directed to the administration ofmedical fluid to a patient by a medical practitioner using the disclosedneedleless connector, it is to be understood that this description isonly an example of usage and does not limit the scope of the claims.Various aspects of the disclosed needleless connectors may be used inany application where it is desirable to prevent a valve from breachinga primary seal when in the connector is in a non-accessed state.

The disclosed needleless connector overcomes several challengesdiscovered with respect to certain conventional connectors. Onechallenge with certain conventional needleless self-sealing connectorsis that a primary seal may be breached when the self-sealing connectorsare subjected to back pressure from the flow of fluid within an IV set.Because such a breach of the primary seal may result in the malfunctionof the connector and failure in the administration of the medical fluid,such a breach is undesirable.

Therefore, in accordance with the present disclosure, it is advantageousto provide a needleless connector as described herein that eliminates orsubstantially reduces potential back pressure-related problems withinthe needleless connector during use without unduly limiting an airchannel of the needleless connector. The disclosed needleless connectorprovides a support member on a base that substantially prevents theflexible valve from extending into a recess of the base.

FIG. 1A-1B are cross-sections of a conventional needleless connector100. Connector 100 includes a housing 120, which has female luer fitting101 at the proximal end, a base 130, which has male luer fitting 102 atthe distal end, and a valve element 103. The valve element 103 sitsinside housing portion 120 and on top of the base 130. The proximalportion of valve element 102 has a “smiley cut” 106. Air channels 172pass from the internal cavity 104 of the valve element 103 through thebase 130 into the open space around the male Luer fitting 102. The valveelement 103 has a shoulder 107 that continuously contacts a ridge 122within the interior of the housing 120, when the needleless connector100 is not being accessed (i.e., a mating medical implement is notcoupled to the self-sealing port) to form a primary seal that prohibitsfluid of the fluid flow channels 174 from exiting the needlelessconnector 100 through the female luer fitting 101.

The cross-section of FIG. 1B is taken perpendicular to the cross-sectionof FIG. 1A. In this view, the two dimples 106 formed in an externalsurface of the valve element 103 are visible. Fluid flow channels 174pass from a cavity 22 within the housing 120 through the base 130 to aflow passage 132 within the male Luer fitting 102.

FIG. 1C is a perspective view of the base 130 of the conventionalconnector 100 of FIG. 1A. The base 130 has a rim 150 surrounding arecess 140 with a bottom surface 160. The valve base 105 of the valveelement 102 (not shown in FIG. 1C) fits over the rim 150. The entrancesto the air channels 172 are visible within the cavity 140. The entranceto one of the fluid flow channels 174 is visible on the side of the base130.

FIG. 1D is a cross-section of the conventional connector 100 of FIG. 1Awhen mated with compatible male connector 20. In operation, when thefemale fitting 101 of the connector 100 is accessed by a male fitting20, the valve element 103 is sufficiently elastic so that it can bendout of the way to allow fluid flow and then return to its original shapeafter the male fitting 20 is disconnected. The collapsible valve element103 is shown in a collapsed position after insertion of the maleconnector 20 into female fitting 101. Fluid can flow from the maleconnector 20 around the collapsed valve element 103 is into channelsincluding the fluid flow channels 174 of the base 130 and into the maleluer fitting 102 for exiting the connector 100. The valve base 105 ofthe valve element 103 deformed under the pressure of the male connector20, with the deformation being described in greater detail with respectto FIG. 1E.

Connector 100 is a positive displacement device. When a new connectionis made at the female fitting 101, the internal cavity 104 is reducedand the connector 100 draws fluid in either through the female fitting101 or the male fitting 102 of the base 130 via the fluid channel 222.When a disconnection is made at the female luer fitting 101, theconnector 100 expels fluid from the fluid channel 222, effectivelyflushing the connector 100 and, if one of the lines attached to fittings101 or 102 are connected to a patient, avoids drawing blood into theline.

FIG. 1F is a cross-section of the conventional connector 100 of FIG. 1Awhen the male connector 20 (shown in FIG. 1D) has been removed and backpressure 134 is applied to the valve element 103 from the fluid channel222 fluidly connected to a line (not shown) attached to the male fitting102 of the base 130. When back pressure 134 is applied within theinterior of the housing 120, the generally cylindrical shape of thevalve element 103 is deformed to a generally oval-tubular shape. Aproximal force 136 and a distal force 138 result from the deformation ofthe valve element 103 due to its flexible, collapsible properties. Ifthe distal force 138 substantially counteracts the proximal force 136,then the shoulder 107′ may cease to contact the ridge 122 within theinterior of the housing 120, thereby causing a breach of the primaryseal of the needleless connector 100. As similarly discussed withrespect to the force applied by the male connector 20 in FIG. 1C, thevalve base 105 of the valve element 103 is deformed under the pressureof the distal force 138 caused by back pressure 134 of the fluidentering the flow passage 132, with the deformation being described ingreater detail with respect to FIG. 1E.

FIG. 1E is an enlarged view of a portion of FIG. 1D and FIG. 1F. Thecompressive load from the male fitting 20 (see FIG. 1D) or the distalforce 138 caused by back pressure 134 (see FIG. 1F) is transferred bythe wall of the valve element 103 to the valve base 105 and then intothe rim 150. Due to the flexible nature of the valve element 103,however, the interior corner 110 of the valve base 105 may deform andprotrude into the cavity 140 as seen in FIG. 1E.

An example of a needleless connector that eliminates or substantiallyreduces undesirable deformation of the valve element during use is nowdescribed.

FIG. 2 is an exploded view of an exemplary needleless connector 200, inaccordance with various aspects of the present disclosure. The connector200 includes a body 220 defining an internal cavity 204 and having afemale fitting 201, a flexible valve element 203 having a cylindricalportion with a flange 205 extending outward at a distal end of thecylindrical portion 204 and an interior volume 213, and a base 230. Thebase 230 has a rim 250 that defines a recess 240 with two air passages272 passing from a recess 240 through the body 230 to the ambientenvironment around the male fitting (not visible in FIG. 2 ), and one ormore support members 280 that extend from the rim 150 laterally into therecess 240. When assembled, a top surface of the rim 250 is in contactwith the valve base or flange 105. The recess 240 has a bottom surface260 that is distally separated from the top surface of the rim 250. Twopassages 274 (only one visible in FIG. 2 ) pass through the base 230 andare configured similar to passages 174 in FIGS. 1B and 1C.

In certain embodiments, the base 230 comprises a polycarbonate material.However, the base 230 as well as the body 220 of the connector 100 maycomprise one or more materials including, but not limited to, polyester,polyethylene, and/or other thermoplastics. Additionally, one or both ofthe base 230 and the body 220 may be clear or translucent, therebyenabling partial visibility of fluid within the connector 200. Incertain embodiments, the flexible valve element 203 comprises asilicone.

In certain embodiments, the needleless connector 200 may have certainsimilar characteristics and functionality similar to that of theconventional connector 100. For example, in certain embodiments, theneedleless connector 200 includes certain aspects that are differentfrom the connector 100 such as a smaller overall length, smaller portdiameter, smaller fluid path channels, smaller overall diameter,different valve operation, different materials composition, etc. Forexample, in certain embodiments, base section 230 is smaller than base130. In this regard, certain embodiments derive a benefit from the basesection having a support member.

As illustrated, the recess 240 of the base 230 is aligned to interfacewith the interior volume 213 of the flexible valve element 203 uponassembly. Embodiments of the support members 280 provide a mechanism foreliminating or substantially reducing intrusion of the flexible valveelement 203 into the recess 240. Various examples of the configurationof support members 280 are discussed with respect to FIGS. 3-5 . Whenassembled, the flange 205 of the flexible valve element 203 is capturedbetween the body 220 and base 230, as is discussed in greater detailwith respect to FIG. 6 .

FIG. 3 is a top view of the base 230 of FIG. 2 , in accordance withvarious aspects of the present disclosure. In this example embodiment,six protrusions 282A-282F are disposed along portions of the rim 250 andlongitudinally extend into recess 240. In certain embodiments, there maybe more or fewer protrusions 280. In certain embodiments, theprotrusions 282A-282F have rounded tips as shown in FIG. 3 . In certainembodiments, the protrusions 282A-282F may have sharp corners orstraight edges. One or more of the protrusions 282A-282F may be disposedover the bottom surface 260. In the example shown in FIG. 3 , all six ofthe protrusions 282A-282F are fully over the bottom surface 260, i.e. noportion of the protrusions 282A-282F overhang either of the flowpassages 272. In this regard, the protrusions 280A-280F are arrangedsuch that the cross-sectional area of the air passage 272 is not reducedor obstructed while providing support for the flange 205 of the valvemember 203. Obstructing or reducing the cross-sectional area of the airpassage 272 could decrease the performance of the valve member 203 incertain embodiments, for example, when air is required to rapidly escapeor enter the interior volume 213 of the valve member 203 whilecollapsing or expanding, respectively. In some embodiments, one or moreprotrusions 280 may extend partially or completely over one of the airpassages 272. The support of the flange 205 that is provided by theprotrusions 280A-280F is discussed in greater detail with respect toFIG. 6D.

FIGS. 4-5 are top views of other embodiments 231, 232 of the base, inaccordance with various aspects of the present disclosure. FIG. 4illustrates another example of a base 231 having protrusions 282A-282Cdisposed over a portion of rim 250 on one side of a center axis 301 andno protrusions on the other side of axis 301. Provision of protrusions282A-282C on a single side may provide, for example, improved control ofthe collapse of the flexible valve element 203.

FIG. 5 illustrates another example of a base 232. According to certainembodiments, the base 232 comprises one or more support ribs 285A-285C.In this example, each of the ribs 285A-285C extends across the recess240 from a first portion of the rim 250 to a second portion of the rim250. In some embodiments, the ribs 285A-285C are the full height of rim250 and continuous for the entire length of the respective ribs285A-285C. In other embodiments, one or more of the ribs 285A-285C mayhave open segments proximal the bottom surface 260 to facility an airpathway across the bottom surface 260 between the two apertures 272. Incertain embodiments, each rib 285A-285C may be integral with the wall250 and/or bottom 260 of the base 230.

In some embodiments, the support members 280, for example theprotrusions 282 of FIG. 3 and/or the ribs 285 of FIG. 5 , may extendbetween 0.01 and 0.15 inches above the rim 250. In certain embodiments,the support members 280 may extend 0.05 inches above the rim 250. Incertain embodiments, the support members 280 may extend the samelongitudinal length. In other embodiments, the support members 280 mayhave different longitudinal lengths. In certain embodiments, the supportmembers 280 may have various portions that are recessed below, flushwith, or raised above the top surface of the rim 250.

FIG. 6A is a cut-away perspective view of the assembled needlelessconnector 200 of FIG. 2 , in accordance with various aspects of thepresent disclosure. The flange 205 has engaged the rim 250 of base 230,and then the body 220 placed over the flexible valve element 203 andsealingly coupled to the body 230, thereby capturing a portion of theflange 205 between the body 220 and base 230. The various sections B-B,C-C, and D-D are shown in FIGS. 6B-6D, respectively. The top opening toone of the air channels 272 is visible adjacent to the bottom surface260. This embodiment of valve element 203 has internal dimples 215 thatextend over a portion of a circumference of the surface of the internalvolume 213.

FIGS. 6B-6D are cut-away perspective views of the complete connector 200at locations shown in FIG. 6A, in accordance with various aspects of thepresent disclosure. FIG. 6B is taken above the flange 205 and shows thecylindrical portion of the valve element 203 disposed within the body220. The interior volume 213 is visible within the valve element 203while fluid channels 222 are visible as formed in the interior wall ofbody 220 and external to the valve element 203.

FIG. 6C depicts a cross-section taken at the bottom surface of theflange 205. The outer diameter of the flange 205 has extended radiallyoutward while maintaining an inner diameter matching the interior volume213. The lower portions of fluid channels 222 are visible and providethe fluid flow path around the flange 205. The dash-line circle 216indicates a projection of the outer surface of the cylindrical portion204 onto the cross-sectional surface. In certain embodiments, the circle216 divides the bottom surface of the flange 205 into an inner area 207Aand an outer area 207B.

FIG. 6D depicts a cross-section taken through the protrusions 280A-280Fjust below the bottom surface of the flange 205. It can be seen how theprotrusions 280A-280F extend inward over the inner area 207A and pastthe inner diameter of the flange 205, thereby providing complete supportto the flange 205 and preventing the deformation seen in theconventional connector 100, for example as shown in FIG. 1E. In certainembodiments, the protrusions 280A-280F may be aligned, or oriented in adefined relationship, with respect to the dimples 215 of the valveelement 203. In certain embodiments, one or more of the protrusions280A-280F may not extend past the inner diameter of the flange 205.

Referring to FIG. 7 , an exemplary needleless connector 200 is shownwhen the needleless connector 200 is in a fluidly connected, butnon-accessed state. As illustrated, the needleless connector 200 isbeing subjected to back pressure 234 applied to the valve element 203from the fluid channel 322 fluidly connected to a line (not shown)attached to the male fitting 202 of the base 230. The base 230 hasprotrusions 280A-280F that provide support the valve element 203,particularly the flange 205, when back pressure 234 is applied to thevalve element 203 within the body 220. Thus, the protrusions 280A-280Fof the base 230 eliminate or substantially prevent deformation of theflange 205 into the recess 240 of the base 230. Therefore, in contrastwith FIG. 1F, a proximal force 236 caused by back pressure 234 will beincreased and a distal force 238 will be eliminated or substantiallyreduced. Accordingly, movement of the valve element 203 will occur inthe proximal direction toward the female fitting 201, thereby furtherimproving the primary seal of the needleless connector 200 between ashoulder 307 of the valve element 203 and an interior ridge 323 of thebody 220 when being subjected to back pressure 234 in the fluidlyconnected, but non-accessed state.

The present disclosure is provided to enable any person skilled in theart to practice the various aspects described herein. The disclosureprovides various examples of the subject technology, and the subjecttechnology is not limited to these examples. Various modifications tothese aspects will be readily apparent to those skilled in the art, andthe generic principles defined herein may be applied to other aspects.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically so stated, but rather “one or more.”Unless specifically stated otherwise, the term “some” refers to one ormore. Pronouns in the masculine (e.g., his) include the feminine andneuter gender (e.g., her and its) and vice versa. Headings andsubheadings, if any, are used for convenience only and do not limit theinvention.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs. In one aspect, various alternative configurationsand operations described herein may be considered to be at leastequivalent.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples. A phrase such as an aspectmay refer to one or more aspects and vice versa. A phrase such as an“embodiment” does not imply that such embodiment is essential to thesubject technology or that such embodiment applies to all configurationsof the subject technology. A disclosure relating to an embodiment mayapply to all embodiments, or one or more embodiments. An embodiment mayprovide one or more examples. A phrase such an embodiment may refer toone or more embodiments and vice versa. A phrase such as a“configuration” does not imply that such configuration is essential tothe subject technology or that such configuration applies to allconfigurations of the subject technology. A disclosure relating to aconfiguration may apply to all configurations, or one or moreconfigurations. A configuration may provide one or more examples. Aphrase such a configuration may refer to one or more configurations andvice versa.

In one aspect, unless otherwise stated, all measurements, values,ratings, positions, magnitudes, sizes, and other specifications that areset forth in this specification, including in the claims that follow,are approximate, not exact. In one aspect, they are intended to have areasonable range that is consistent with the functions to which theyrelate and with what is customary in the art to which they pertain.

In one aspect, the term “coupled” or the like may refer to beingdirectly coupled. In another aspect, the term “coupled” or the like mayrefer to being indirectly coupled.

Terms such as “top,” “bottom,” “front,” “rear” and the like if used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Various items may be arranged differently (e.g., arranged in a differentorder, or partitioned in a different way) all without departing from thescope of the subject technology. All structural and functionalequivalents to the elements of the various aspects described throughoutthis disclosure that are known or later come to be known to those ofordinary skill in the art are expressly incorporated herein by referenceand are intended to be encompassed by the claims. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the claims. No claimelement is to be construed under the provisions of 35 U.S.C. § 112,sixth paragraph, unless the element is expressly recited using thephrase “means for” or, in the case of a method claim, the element isrecited using the phrase “step for.” Furthermore, to the extent that theterm “include,” “have,” or the like is used, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The Title, Background, Summary, Brief Description of the Drawings andAbstract of the disclosure are hereby incorporated into the disclosureand are provided as illustrative examples of the disclosure, not asrestrictive descriptions. It is submitted with the understanding thatthey will not be used to limit the scope or meaning of the claims. Inaddition, in the Detailed Description, it can be seen that thedescription provides illustrative examples and the various features aregrouped together in various embodiments for the purpose of streamliningthe disclosure. This method of disclosure is not to be interpreted asreflecting an intention that the claimed subject matter requires morefeatures than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed configuration or operation. The followingclaims are hereby incorporated into the Detailed Description, with eachclaim standing on its own as a separately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but is to be accorded the full scope consistent with thelanguage claims and to encompass all legal equivalents. Notwithstanding,none of the claims are intended to embrace subject matter that fails tosatisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should theybe interpreted in such a way.

What is claimed is:
 1. A needleless connector, comprising: a valveelement at least partially disposed within a body, the valve elementcomprising a cylindrical portion having an inner surface, thecylindrical portion comprising an outwardly extending flange at a distalend, the flange having a bottom surface, and the inner surface definingan interior volume; and a base comprising a rim defining a recess, anair passage extending through the recess to an ambient environment, afluid flow passage through the base and separate from the air passage,wherein a portion of the rim extends into the recess to form at leastone support member, the rim comprising a top surface defining a firstplane, wherein, when the top surface of the rim is engaged against anouter area of the bottom surface of the flange, the at least one supportmember engages an inner area of the bottom surface of the flange, andthe at least one support member is configured to resist deformation ofthe flange toward the recess.
 2. The needleless connector of claim 1,wherein the recess comprises a bottom surface distally separated fromthe top surface of the rim.
 3. The needleless connector of claim 2,wherein the bottom surface of the recess defines a second plane spacedapart from the first plane.
 4. The needleless connector of claim 2,wherein the bottom surface of the recess extends from a respective firstpoint on the rim that is on one side of a center axis, the center axispassing through a center of the recess and a center of the air passage,to a respective second point on the rim that is on the other side of thecenter axis.
 5. The needleless connector of claim 1, wherein the atleast one support member extending past the inner surface of thecylindrical portion of the valve element forming the interior volume ofthe valve element.
 6. The needleless connector of claim 1, wherein thebase comprises another air passage, and the at least one support memberextends between the air passage and the another air passage.
 7. Theneedleless connector of claim 1, wherein the at least one support memberextends inwardly of an inner area of the bottom surface of the flange.8. The needleless connector of claim 1, wherein the at least one supportmember extends longitudinally parallel to a longitudinal axis of the airpassage.
 9. The needleless connector of claim 1, wherein, when the valveelement is connected to the base, the interior volume is formed withinthe valve element, and the fluid flow passage is formed external to thevalve element.
 10. A needleless connector, comprising: a body having aport forming a proximal end of the needleless connector, a base forminga distal end of the needleless connector, and a valve element at leastpartially disposed within an internal cavity of the body; the valveelement comprising a cylindrical portion having an inner surface and anoutwardly extending flange, the flange having a bottom surface and theinner surface defining an interior volume; the base comprising a rimdefining a recess, an air passage extending through the recess to anambient environment, a fluid flow passage through the base and separatefrom the air passage, wherein a portion of the rim extends into therecess to form at least one support member, the rim comprising a topsurface defining a first plane, the air passage extending from therecess through the base to an ambient environment; wherein, when the topsurface of the rim is engaged against an outer area of the bottomsurface of the flange, the at least one support member engages an innerarea of the bottom surface of the flange, and the at least one supportmember is configured to resist deformation of the flange toward therecess.
 11. The needleless connector of claim 10 wherein the recesscomprises a bottom surface distally separated from the top surface ofthe rim.
 12. The needleless connector of claim 11, wherein the bottomsurface of the recess defines a second plane spaced apart from the firstplane.
 13. The needleless connector of claim 11, wherein the bottomsurface of the recess extends from a respective first point on the rimthat is on one side of a center axis, the center axis passing through acenter of the recess and a center of the air passage, to a respectivesecond point on the rim that is on the other side of the center axis.14. The needleless connector of claim 10, wherein the at least onesupport member extending past the inner surface of the cylindricalportion of the valve element forming the interior volume of the valveelement.
 15. The needleless connector of claim 10, wherein the basecomprises another air passage, and the at least one support memberextends between the air passage and the another air passage.
 16. Theneedleless connector of claim 10, wherein the at least one supportmember extends inwardly of an inner area of the bottom surface of theflange.
 17. The needleless connector of claim 10, wherein the at leastone support member extends longitudinally parallel to a longitudinalaxis of the air passage.
 18. The needleless connector of claim 10,wherein, when the valve element is connected to the base, the interiorvolume is formed within the valve element, and the fluid flow passage isformed external to the valve element.